Alleviation by Fisetin of Frailty, Inflammation, and Related Measures in Older Adults (AFFIRM-LITE)

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This is a pilot study to test the efficacy of the anti-inflammatory drug (Fisetin) in reducing inflammatory factors in blood in elderly adults and to test the efficacy of the drug (Fisetin) in reducing frailty and markers of inflammation, insulin resistance, and bone resorption in elderly adults.

Condition or disease

Intervention/treatment

Phase

Frail Elderly Syndrome

Dietary Supplement: FisetinDrug: Placebo oral capsule

Phase 2

Detailed Description:

To the researchers' knowledge, there are no published studies utilizing Fisetin in alteration of frailty markers. Several studies involve use of Fisetin for its anti-oxidative and anti-apoptotic effects in animal models. Fisetin may reduce oxidative stress, alleviate hyperglycemia, and improve kidney function. No one has evaluated the biologic markers of inflammation and frailty in older adults. The researchers plan to evaluate markers of frailty and markers of inflammation, insulin resistance, and bone resorption while maintaining bone formation in older adults.

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Layout table for eligibility information

Ages Eligible for Study:

70 Years and older (Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria

• Age ≥ 70 years

Exclusion Criteria

Unable or unwilling to give informed consent

Pregnant

Body weight >150 kg or body mass index (BMI) > 50

QTc>450 msec

Total bilirubin >2X upper limit of normal

Inability to tolerate oral medication

Abnormality in any of the screening laboratory studies (see below)

Human immunodeficiency virus infection

Known active hepatitis B or C infection

Invasive fungal or viral infection

Known hypersensitivity or allergy to fisetin

Uncontrolled pleural/pericardial effusions or ascites

New/active invasive cancer except non-melanoma skin cancers

Subjects taking medications that are sensitive to substrates or substrates with a narrow therapeutic range for CYP3A4, CYP2C8, CYP2C9, or CYP2D6 or strong inhibitors or inducers of CYP3A4 (e.g. cyclosporine, tacrolimus or sirolimus). If antifungals are absolutely necessary from an infectious disease perspective, then they will be allowed only if the levels are therapeutic.

Strong inhibitors of CYP3A4. See Appendices 1-3.

Tyrosine kinase inhibitor therapy

Known hypersensitivity or allergy to fisetin

Subjects on quinolone antibiotic therapy for treatment or for prevention of infections within 10 days.

Subjects taking H2-antagonists and unwilling to discontinue therapy for 1 week before and 2 weeks following enrollment.

In order to ensure vitamin D sufficiency, we will also exclude subjects with serum 25-hydroxyvitamin D levels of < 20 ng/ml.

Presence of any condition that the Investigator believes would put the subject at risk or would preclude the patient from successfully completing all aspects of the trial.

Behavioral Modification - Participants will be educated about the risk of excessive caffeine usage. Participants will be encouraged to reduce use by 50% prior to and during the 2-day drug dosing period. Due to drug-drug interaction, subjects may not clear the caffeine from their system properly/as usual.